Kneu Health Launches in U.S

• Built on one of the world's largest Parkinson's and dementia datasets and adopted across major U.S. health systems and NHS Trusts, Kneu is creating a population-scale foundation for managing neurodegenerative decline
• Kneu's smartphone platform, FDA-cleared for Parkinson's tremor measurement, is the first clinically validated system to track motor, speech and cognitive change entirely by phone, embedding proactive monitoring into daily life and clinical workflows
• Powered by clinically trained AI models that turn voice, movement and memory into predictive biomarkers, Kneu helps detect neurological decline earlier and support timely intervention

BOSTON, July 29, 2025 — Kneu Health, a precision neurology platform for Parkinson's and dementia, today announced FDA 510(k) clearance for its smartphone-based tremor measurement module, designed to quantify tremor in adults with mild to moderate Parkinson's disease. This marks the first known fully phone-based system, with no wearable or in-clinic hardware, for measuring motor symptoms in Parkinson's care.

The clearance represents one part of a broader groundbreaking platform that helps clinicians and families monitor cognitive and motor changes from home. Built for everyday use on a standard smartphone, Kneu guides Parkinson's and dementia patients through short, structured tasks that analyze speech, movement and memory, generating predictive biomarkers that flag early signs of neurological decline weeks or even months before traditional tools detect a problem. Kneu's FDA clearance for Parkinson's tremor measurement coincides with its formal entry into the U.S. market, where the platform is already live for Parkinson's care at Mass General Brigham.

Parkinson's disease affects more than one million Americans today, and that number is projected to grow 20% by 2030. Dementia impacts over 6 million people in the US, with global cases expected to triple by mid-century. While the number of patients increases, neurologist shortages strain health systems nationwide. With the oldest baby boomers now turning 79, providers desperately need scalable, humane brain care. However, most patients go six months or longer between neurology appointments, often living their lives without any structured support. During those silent months, symptoms continue to progress, causing people to fall, hallucinate and miss medications. Caretakers, including family and friends, often have no objective way to gauge what's actually happening, because the reality is tangled in a web of symptoms, daily variability and the complexity of life itself. Only when a hospitalization forces serious action does the full severity of disease progression come into focus.

Built on over a decade of research at the University of Oxford and already validated across NHS Trusts in the UK, Kneu brings proactive, high-resolution brain care into the home. Designed to detect deterioration before it spirals out of control, the platform guides patients through a series of short assessments that measure changes in voice, memory, movement, and cognition. These subtle shifts are often missed in clinic but are captured through Kneu's repeatable, research-validated measurements. Clinicians receive scores that help them prioritize care, detect escalation early, adjust existing treatments and justify more advanced interventions, all without adding administrative burden.

Platform highlights:

• Requires no additional hardware or in-clinic setup; patients use their own phones at home
• Integration with major EHRs and support for Remote Therapeutic Monitoring (RTM) billing
• Passive and active smartphone sensors track changes in cognition, movement and speech
• Generates composite scores structured insights aligned to clinical decision-making
• Backed by 10+ years of real-world patient data

"For too long, we've treated brain health reactively, standing by until someone is visibly declining before stepping in. We can no longer wait for accidents to happen to justify the next level of care for our loved ones"

Caroline Cake Co-founder & CEO

"For too long, we've treated brain health reactively, standing by until someone is visibly declining before stepping in. We can no longer wait for accidents to happen to justify the next level of care for our loved ones," said Caroline Cake, CEO and co-founder of Kneu Health. "Kneu offers health systems a new path forward, where high-frequency monitoring, predictive insights and home-based tools expand the reach of neurologists, relieve pressure on frontline staff and raise the standard of care for millions of patients and families."

Kneu's impact goes beyond convenience. By generating structured, high-frequency data between visits, the platform helps care teams triage patients based on risk, track disease progression over time, and intervene earlier, often before visible symptoms appear. This insight supports more confident decision-making and documentation, unlocking opportunities for proactive care and reimbursement. With seamless integration into major EHR systems, Kneu fits directly into clinical workflows, helping neurologists, geriatricians and primary care teams manage growing patient volumes without increasing administrative burden or headcount.

"People often overlook voice or gait changes because they assume they're minor, but they're among the earliest and most actionable signals of neurological decline," said Dr. Kinan Muhammed, Kneu Health's co-founder and Chief Medical Officer. "By capturing these subtle shifts longitudinally and objectively, Kneu allows us to anticipate deterioration, personalize treatment and reduce the burden on patients, caregivers and care teams alike."

Early findings from Kneu's UK deployments suggest the platform may detect neurological changes earlier than traditional assessments; in some cases, up to 18 months ahead. Its digital phenotyping methodology has been validated across peer-reviewed studies published in Neurology and the Journal of Neurology, Neurosurgery & Psychiatry (JNNP).

Kneu is in active discussions with additional health systems and payer partners to scale its reach across the U.S. The company's clinical foundation and seamless, smartphone-based delivery make it a powerful new option for expanding access to specialist-level brain care. By eliminating the need for in-clinic setup or expensive hardware, Kneu is also well-suited to serve communities left behind by traditional models, including rural areas, lower-income families and populations with limited neurologist access.

About Kneu Health

Kneu Health is pioneering a new model of precision neurology for Parkinson's and dementia: care that is proactive, compassionate, and designed for the realities of everyday life. Built on one of the most advanced longitudinal datasets in Parkinson's care — the Oxford Parkinson's Disease Centre Discovery Cohort — Kneu's smartphone-based platform turns structured at-home assessments into actionable insights, enabling clinicians to detect decline earlier and act before symptoms escalate. The technology analyzes speech, movement, memory, and cognition in just minutes a day, using trained models to generate predictive scores and digital biomarkers that inform treatment and care. Kneu is working with leading U.S. health systems to expand access, ease workforce strain, and set a new standard for brain health monitoring.